Trial Outcomes & Findings for Comorbidities Associated With Migraine and Patent Foramen Ovale (CAMP) (NCT NCT01257880)
NCT ID: NCT01257880
Last Updated: 2011-09-27
Results Overview
Embolic tracks on transcranial Doppler at rest and following calibrated Valsalva maneuver
COMPLETED
31 participants
Baseline
2011-09-27
Participant Flow
Over a 20-month period (January 2010 to May 2011), 127 subjects were screened and 31 were enrolled from Swedish Medical Center and the University of Washington Medical Center, including 19 with MA + PFO and 12 with MA - PFO.
Of 127 potential subjects screened, reasons for exclusion included the following: 22 (17%) chronic migraine or medication overuse headache; 9 (7%) topiramate use; 6 (5%) stroke or multiple sclerosis; 39 (31%) other (declined, low frequency); 12 (9%) small to medium sized PFO; 8 (6%) fetal origins.
Participant milestones
| Measure |
Control (Absence of PFO)
Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
|
Large PFO
Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
19
|
|
Overall Study
COMPLETED
|
12
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comorbidities Associated With Migraine and Patent Foramen Ovale (CAMP)
Baseline characteristics by cohort
| Measure |
Control (Absence of PFO)
n=12 Participants
Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
|
Large PFO
n=19 Participants
Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
37 years
STANDARD_DEVIATION 10 • n=5 Participants
|
35 years
STANDARD_DEVIATION 11 • n=7 Participants
|
35 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
19 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineEmbolic tracks on transcranial Doppler at rest and following calibrated Valsalva maneuver
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselineThe percentage change in basilar artery blood flow velocity from baseline between hypercapnia (increased blood CO2) and hypocapnia (decreased blood CO2), as measured by transcranial Doppler during a single testing period. This is calculated using the following equation: VMR = 100 x (VelocityHYPERCAPNIA - VelocityHYPOCAPNIA) / VelocityBASELINE
Outcome measures
| Measure |
Control (Absence of PFO)
n=12 Participants
Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
|
Large PFO
n=19 Participants
Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
|
|---|---|---|
|
Cerebral Vasomotor Reactivity (VMR)
|
89 Percentage change
Standard Deviation 20
|
97 Percentage change
Standard Deviation 24
|
PRIMARY outcome
Timeframe: BaselinePlatelet-poor plasma levels of sCD40L and P-selectin, and serum concentration of TXB2.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Following one night of a home sleep studyPopulation: The analysis was based on per protocol.
An apnea-hypopnea index (AHI) \>10 per hour during a home sleep study, defined as at least 5 hours of recorded data on the portable sleep monitor instrument for either the apnea-hypopnea index (AHI) or oxygen desaturation index (ODI) and at least 3 hours for the other index. The scale adopted for assessment of sleep apnea is as follows: AHI \< 5, optimal; AHI 5-10, equivocal, participant may have sleep apnea; AHI \>10, sleep apnea highly likely.
Outcome measures
| Measure |
Control (Absence of PFO)
n=11 Participants
Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
|
Large PFO
n=16 Participants
Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
|
|---|---|---|
|
Sleep Apnea, Number of Participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: BaselineCognitive function will be assessed by a battery of performance-based neuropsychological tests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineMeasurement of number of times per hour blood oxygen saturation decreases by at least 4% during home sleep study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 5 years prior to enrollmentPresence and severity of white matter lesions on magnetic resonance imaging, taken within 5 years prior to study enrollment. Subjects will not have magnetic resonance imaging performed as part of this study. Films will be requested and an independent neuroradiologist will assess presence of white matter lesions.
Outcome measures
Outcome data not reported
Adverse Events
Large PFO
Control (Absence of PFO)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place